ONO-4538 Phase II Rollover Study (ONO-4538-98)

June 1, 2025 updated by: Ono Pharmaceutical Co. Ltd

A Multicenter, Open-label, Phase II Pan-Tumor Study in Patients Who Have Participated in Trials to Investigate Efficacy and Safety of ONO-4538 as Monotherapy or in Combination With Other Therapies and Are Continuing ONO-4538 Treatment (ONO-4538-98)

This study is intended to confirm the long-term safety of ONO-4538 in pan-tumor participants being treated with ONO-4538 monotherapy or in Combination with Other Therapies in clinical trials.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Japan
      • Chiba, Japan
        • Recruiting
        • Chiba Clinical Site2
      • Fukuoka, Japan
        • Recruiting
        • Fukuoka Clinical Site2
      • Fukuoka, Japan
        • Recruiting
        • Fukuoka Clinical Site3
      • Hiroshima, Japan
        • Recruiting
        • Hiroshima Clinical Site1
      • Kyoto, Japan
        • Recruiting
        • Kyoto Clinical Site1
      • Okayama, Japan
        • Recruiting
        • Okayama Clinical Site1
      • Osaka, Japan
        • Recruiting
        • Osaka Clinical Site2
    • Chiba
      • Kashiwa, Chiba, Japan
        • Recruiting
        • Chiba Clinical Site1
    • Ehime
      • Matsuyama, Ehime, Japan
        • Completed
        • Ehime Clinical Site1
    • Fukuoka
      • Kurume, Fukuoka, Japan
        • Recruiting
        • Fukuoka Clinical Site1
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Recruiting
        • Hokkaido Clinical Site1
    • Hyogo
      • Akashi, Hyogo, Japan
        • Recruiting
        • Hyogo Clinical Site1
    • Kanagawa
      • Yokohama, Kanagawa, Japan
        • Recruiting
        • Kanagawa Clinical Site1
    • Oita
      • Yufu, Oita, Japan
        • Recruiting
        • Oita Clinical Site1
    • Osaka
      • Suita, Osaka, Japan
        • Recruiting
        • Osaka Clinical Site1
      • Takatsuki, Osaka, Japan
        • Recruiting
        • Osaka Clinical Site3
    • Saitama
      • Hidaka, Saitama, Japan
        • Recruiting
        • Saitama Clinical Site1
      • Kitaadachi-gun, Saitama, Japan
        • Recruiting
        • Saitama Clinical Site2
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • Recruiting
        • Tokyo Clinical Site3
      • Chuo-ku, Tokyo, Japan
        • Recruiting
        • Tokyo Clinical Site2
      • Koto-ku, Tokyo, Japan
        • Recruiting
        • Tokyo Clinical Site1
      • Shinjuku-ku, Tokyo, Japan
        • Recruiting
        • Tokyo Clinical Site4
  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Recruiting
        • Daegu Clinical Site1
      • Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Gyeonggi-do Clinical site1
      • Incheon, Korea, Republic of
        • Recruiting
        • Incheon Clinical Site1
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul Clinical Site1
      • Seoul, Korea, Republic of
        • Completed
        • Seoul Clinical Site2
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul Clinical Site3
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul Clinical Site4
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul Clinical Site5
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul Clinical Site6
  • Taiwan
      • Kaohsiung, Taiwan
        • Completed
        • Kaohsiung Clinical Site1
      • Kaohsiung, Taiwan
        • Completed
        • Kaohsiung Clinical Site2
      • Tainan, Taiwan
        • Recruiting
        • Tainan Clinical Site1
      • Tainan, Taiwan
        • Recruiting
        • Tainan Clinical Site2
      • Taipei, Taiwan
        • Recruiting
        • Taipei Clinical Site1
      • Taipei, Taiwan
        • Recruiting
        • Taipei Clinical Site2
      • Taoyuan, Taiwan
        • Recruiting
        • Taoyuan Clinical Site1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participant who is being treated with ONO-4538 as monotherapy or in Combination with Other Therapies in clinical trials
  2. Participant who is eligible for ONO-4538 monotherapy or in combination with other therapies as per the clinical trials, and/or investigator-assessed clinical benefit

Exclusion Criteria:

  1. Participant judged to be incapable of providing consent for reasons such as concurrent dementia
  2. Participant judged by the investigator to be inappropriate as participants of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ONO-4538 Monotherapy cohort
480 mg of ONO-4538 IV Q4W or 240 mg of ONO-4538 IV Q2W per the investigator's choice
Drug: ONO-4538
IV infusion over 30 minutes
Experimental: Combination therapy cohort
ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin [SOX] therapy , Capecitabine + Oxaliplatin [CapeOX] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study.
Drug: ONO-4538
IV infusion over 30 minutes
Drug: oxaliplatin
IV infusion over 2 hours
Drug: S-1
Administered orally twice daily
Drug: capecitabine
Administered orally twice daily
Drug: bevacizumab
IV infusion over 30 minutes
Drug: temozolomide
Administered orally once daily for 5 days every 28 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (Aes)
Time Frame: From Day 1 up to 28 days after the end of the treatment phase
(non)
From Day 1 up to 28 days after the end of the treatment phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ono Pharmaceutical Co. Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ONO-4538-98
  • jRCT2080225345 (Registry Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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